S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Completed · Phase 1/Phase 2

Conditions studied: Stage IV Pancreatic Cancer

In brief

This randomized phase I/II trial is studying the side effects and best dose of monoclonal antibody therapy when given together with gemcitabine hydrochloride and erlotinib hydrochloride and to see how well they work compared with giving gemcitabine hydrochloride and erlotinib hydrochloride alone as first-line therapy in treating patients with metastatic pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving erlotinib hydrochloride and gemcitabine hydrochloride together with monoclonal antibody therapy may kill more tumor cells.

Key facts

Study ID

NCT00617708

Run by

National Cancer Institute (NCI)

People needed

134

Starts

2008-03-01

Expected to finish

2014-02-25

Last updated by the study team

2022-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed pancreatic adenocarcinoma
• Stage IV disease (any T, any N, M1 [distant metastases])
• Unresectable disease
• Histologic diagnosis based on a metastatic site must be compatible with pancreatic cancer
• Measurable and/or nonmeasurable disease
• No endocrine or neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer
• No macroscopic residual disease post-resection as the only site of disease
• No clinically significant ascites
• No known brain metastases
• Patients with neurologic signs or symptoms must undergo brain imaging studies AND studies must be negative for disease
• Zubrod performance status 0-1
• ANC ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Hemoglobin ≥ 9 g/dL
• Leukocytes ≥ 3,000/mcL
• Total bilirubin normal
• SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
• Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Fasting serum glucose < 120 mg/dL or below the ULN
• Patients with diabetes mellitus who meet this criterion must be on a stable dietary or therapeutic regimen for this condition
• INR ≤ 1.5 and PTT ≤ 5 seconds above ULN
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Willing to submit previously collected tumor tissue specimens
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to anti-IGF-1R recombinant monoclonal antibody IMC-A12

Where it is running

• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills - Peninsula Hospitals — Burlingame, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• City of Hope Medical Center — Duarte, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Glendale Memorial Hospital and Health Center — Glendale, California, United States
• Marin General Hospital — Greenbrae, California, United States
• Sutter Health Western Division Cancer Research Group — Greenbrae, California, United States
• University of Southern California — Los Angeles, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• El Camino Hospital — Mountain View, California, United States
• Highland General Hospital — Oakland, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Breast Surgeons Inc — Oakland, California, United States
• Bay Area Tumor Institute — Oakland, California, United States
• Larry G Strieff MD Medical Corporation — Oakland, California, United States
• Tom K Lee Inc — Oakland, California, United States
• University of California Medical Center At Irvine-Orange Campus — Orange, California, United States
• Valley Care Health System - Pleasanton — Pleasanton, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Doctors Medical Center- JC Robinson Regional Cancer Center — San Pablo, California, United States
• NEA Baptist Memorial Hospital — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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